At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

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Job Function:

R&D Product Development:

Job Sub Function:

Biomedical Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Ciudad Juarez, Chihuahua, Mexico, Juarez, Chihuahua, Mexico

Job Description:

J&J Med Tech is recruiting for a Senior Quality Engineer located in Ciudad Juarez, Mexico.

The role of a Senior Quality Engineer at J&J Med Tech is to apply the principles of engineering, mathematics, statistics, organizational excellence, and risk management to help the company achieve two major objectives in support of the J&J Credo:

• Meet and exceed the expectations of our customers

• Achieve and maintain compliance with regulatory expectations

The Senior Quality Engineer provides overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of Johnson and Johnson products, and ensures compliance to good manufacturing practices, international organization for standardization and any other applicable standards. Depending on job needs, a Senior Quality Engineer may work in:

• New product development / new product introduction / new process introduction

• Supply chain (life cycle engineering, manufacturing, assembly, or supplier quality)

• Quality systems and business processes

Key Job Responsibilities:

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Provides leadership in design and implementation of world-class quality engineering to support entire product life cycle with focus on quality engineering activities such as reliability, risk management, analytics/statistical techniques, requirements management, verification & validation, and design control across the lifecycle of the product

• Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes; acts as technical liaison, as needed, between product development, manufacturing, external manufacturers, and suppliers

• Reviews and edits all engineering documentation related to assigned projects, such as technical reports, work instructions and method and process validation; provides review and approval for the release of new products and design changes ensuring quality requirements are met

• Applies intermediate Quality Engineering/Scientific Method techniques and principles to daily tasks and activities. In addition, applies relevant regulations, standards, and industry best practices to assignments.

• Plans and conducts projects and assignments with technical responsibility or strategic input. Receives intermittent, moderately detailed instructions from technical Quality leaders at various levels, in addition to other stakeholders.

• Addresses and corrects product and process complaints through data analysis, continuous product improvement, and/or corrective and preventive actions

• Communicates business related issues or opportunities to next management level

• Oversees audits of quality system categories to assess compliance to process excellence standards

• Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management which outline findings

• Performs and/or oversees complex hands-on and simulated testing for design verification and test method developments; inspects and oversees testing of prototypes, tools, and fixtures after fabrication to ensure that they meet specifications

• Studies specifications, engineering blueprints, tool orders, and shop data and confers with engineering and shop personnel to resolve design problems related to material characteristics, dimensional tolerances, service requirements, manufacturing procedures, and cost

• Ensures personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

• Performs other duties assigned as needed

• May support technical training (i.e. statistics and quality methods) and teaching/mentoring of others

Key Skill and Knowledge Requirements:

• Candidate must have strong analytical problem-solving skills and be able to contribute to or lead root cause investigations using various problem solving techniques and tools, and assess effectiveness of corrective actions

• Candidate must have sound statistical application in areas such as DOE, sampling techniques, regression, reliability, FMEA, hypothesis testing, etc.

• Experience with project management and the ability to work with multiple simultaneous priorities in a highly matrixed environment is required; ability to work cross-culturally is also highly valued

• Demonstrated experience working within a team, obtaining feedback, negotiating, and positively influencing is required

• Ability to understand new concepts quickly, research and maintain ongoing learning of industry regulations is required

• Fundamental technical understanding of manufacturing equipment and processes is required

• Prior experience working with Risk Analysis and Risk Management is also preferred

• Advanced quality systems (AQS) experience preferred

• Knowledge of: Regulatory compliance, GMPs, MDR (Medical Devices Regulation), 510K (Pre-market Notification), PMA (Pre-market Approval), and Government, trade association, industry & medical publications desired

Qualifications:

• A bachelor’s degree in engineering from an accredited engineering or relevant science/technical school is required. A degree in Mechanical, Electrical, or Biomedical Engineering or other equivalent technical degree is preferred.

• Non-STEM graduates with follow-on technical training or experience will also be considered. Appropriate relevant advanced degrees are preferred.

• Generally requires minimum of 4 years’ work experience. Experience in a regulated industry (medical technology, pharmaceutical, or biotechnology) or veterans with leadership experience will be given preference

• Experience with Risk Management (ISO 14971), Medical Device Quality Management System (ISO 13485), Gage repeatability and reproducibility theory and application, statistics, project management (supporting multiple projects simultaneously), and reliability is strongly preferred

• Auditing skills such as

• ISO, QSR (Quality Systems Regulations), MDSAP, and GMP standards are preferred

• An ASQ certification (CQE, CQM, CRE or CQA) is an asset. Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset

• Candidates must be fluent in English, for both written and oral communication

• This position will be located in Ciudad Juarez, Mexico and may have up to 10% of both domestic and international travel

Required Skills: Preferred Skills:

Bioinformatics, Biological Engineering, Biostatistics, Coaching, Critical Thinking, Design of Experiments (DOE), Healthcare Trends, Industry Analysis, Innovation, Medicines and Device Development and Regulation, Product Development, Relationship Building, Research and Development, Researching, SAP Product Lifecycle Management, Standard Scientific Processes and Procedures, Technologically Savvy